Kornimate/medical-research-clean huggingface dataset:
a phase 1/2 study of vx-522 in participants with cystic fibrosis (cf)

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the safety, and tolerability and efficacy of vx-522 in participants 18 years of age and older with cystic fibrosis and a cystic fibrosis transmembrane conductance regulator (cftr) genotype not responsive to cftr modulator therapy.


Eligibility criteria:
key inclusion criteria: * body mass index is less than (\<) 30.0 kilograms per meter square (kg/m\^2) * a total body weight greater than (\>) 50 kg * stable cf disease * cftr gene mutations on both alleles that are not responsive to cftr modulator therapy o example mutations include but are not limited to, mutations that do not produce cftr protein (i.e., class i): nonsense mutations (e.g., g542x, w1282x) and canonical splice mutations (e.g., 621+1g-\>t) * forced expiratory volume in 1 second (fev1) value for sad: greater than or equal to (≥)40 percent (%), mad: ≥ 40% to less than or equal to (≤) 90% key exclusion criteria: * history of uncontrolled asthma within a year prior to screening * history of solid organ or hematological transplantation * hepatic cirrhosis with portal hypertension, moderate hepatic impairment (child pugh score 7 to 9), or severe hepatic impairment (child pugh score 10 to 15) * arterial oxygen saturation on room air less than (\<) 94% at screening other protocol defined inclusion/exclusion criteria may apply.
adipose tissue gene expression and metabolomics links to the gut microbiome-brain axis

Conditions: Obesity

Summary: this study aims to understand how adipose tissue (fat) and the gut microbiota (the bacteria in the gut) may influence brain function and cognition. it has been observed that changes in adipose tissue in animals such as mice and drosophila (a type of insect) affect memory and other brain functions. additionally, it is believed that the gut microbiota also plays an important role in cognition. this study will explore how gene expression in adipose tissue, blood metabolites, and the gut microbiota are related to cognitive function, such as memory and thinking, in individuals with and without obesity. the investigation will also assess whether these factors can predict changes in the brain over time and how they influence sleep, physical activity, and blood sugar regulation. advanced technologies will be used to analyze samples of tissue, blood, and microbiota, with the goal of identifying new mechanisms through which obesity affects the brain. this research may contribute to the development of new diagnostic and therapeutic strategies for cognitive problems in individuals with obesity.


Eligibility criteria:
inclusion criteria: * men and women \>20 years old. * scheduled for surgical intervention to extract adipose tissue. * signed informed consent for study participation. exclusion criteria: * not meeting inclusion criteria. * non-obesity-related systemic diseases (cancer, severe kidney/liver disease). * systemic diseases with intrinsic inflammation (rheumatoid arthritis, crohn's disease, asthma, chronic infections (hiv/tuberculosis)) or any type of infectious disease. * pregnant/breastfeeding women. * persons under legal/administrative restrictions. * those with infection symptoms in the past month. * use of antibiotics/antifungals/antivirals (previous 3 months). * chronic steroidal/anti-inflammatory drug use. * major psychiatric history. * excessive alcohol intake, acute or chronic (\>40g/day (women), \>80g/day (men)) or drug abuse. * immunosuppressants treatment. * participants with severe eating disorders. * serum liver enzymes (got, gpt) above twice the upper limit of normal. obvious signs or symptoms of liver disease, acute or chronic hepatitis. * history of iron balance disorders (e.g., genetic hemochromatosis, hemosiderosis from any cause, atransferrinemia, paroxysmal nocturnal hemoglobinuria). * creatinine greater than 1.2 and glomerular filtration rate below 40. * current treatment for malignant neoplasia, other than basal cell or squamous cell skin cancer. * heart disease classified as class iii or iv, known ischemic cardiovascular disease. * renal failure, history of kidney transplant, or current dialysis treatment. * chronic constipation (bowel movement frequency ≥ 7 days) .

Keywords: continous glucose monitoring cognition gut-microbiota-brain axis
a safety study of sgn-cd19b in patients with b-cell non-hodgkin lymphoma

Conditions: Non-Hodgkin Lymphoma; DLBCL; Diffuse Large B-cell Lymphoma; Grade 3 Follicular Lymphoma

Summary: the study will examine the safety profile of sgn-cd19b administered as a single agent. the main purpose of the study is to estimate the highest dose that does not cause unacceptable side effects of sgn-cd19b in patients with relapsed or refractory aggressive b-cell non-hodgkin lymphoma (nhl) subtypes of diffuse large b-cell lymphoma (dlbcl) and grade 3 follicular lymphoma (fl3). additionally, the pharmacokinetic profile and antitumor activity of sgn-cd19b will be assessed.

sgn-cd19b will be given to patients at increasing doses every 28 days (or on an alternative dosing schedule of every 42 days). individual expansion cohorts of up to approximately 20 patients will be opened at dose levels selected by the safety monitoring committee based on the aggregate known safety and activity data to further define the safety and antitumor activity in refractory and relapsed disease subgroups.

Eligibility criteria:
inclusion criteria: * relapsed, refractory, or progressive disease following at least 2 prior systemic therapies * measurable disease * eastern cooperative oncology group status of 0 or 1 * adequate baseline renal and hepatic function exclusion criteria: * prior treatment with cd19 directed agents unless cd19 expression is confirmed after completion of cd19-directed treatment * known hiv, active hepatitis b or active hepatitis c infection * prior allogeneic stem cell transplant * inadequate lung function * anticancer treatment within 4 weeks of study drug or 2 weeks if patient experienced disease progression on prior treatment

Keywords: non-hodgkin lymphoma antibody-drug conjugate cd19 diffuse large b-cell lymphoma dlbcl grade 3 follicular lymphoma
colon neoadjuvant folfoxiri study

Conditions: Rectal Cancer

Summary: objective tumour response rate to folfoxiri to pre-operative therapy.


Eligibility criteria:
inclusion criteria: * age \>= 18 years of either sex. * ecog performance status 0-1 * measurable disease by recist 1.1 criteria. * histologically confirmed rectal adenocarcinoma (defined as either mid- or low rectal cancer that is located within 12 cm from the anal verge or below the peritoneal reflection) that is previously untreated. * 'high risk' rectal cancer, or rectal cancers that are considered marginally operable where there is a significant risk of positive surgical margin: * t3 (low-lying tumour at or below the levators) or t4, or * tumour infiltrating perirectal fat, or * any t-stage (t1-4) and node-positive tumour (invading surrounding structures or peritoneum) * adequate bone marrow, renal and hepatic function as defined by: absolute neutrophil count \>= 1.5 x 109/l, hemoglobin \>= 9 g/l, platelets \>= 100 x 109/l, calculated creatinine clearance \>= 55 ml/min, total bilirubin =\<1.5 x the upper limit of normal, alanine aminotransferase (alt) =\<2.5 upper limit of normal. exclusion criteria: * known distant metastasis, even if the metastasis has been resected. * history of another invasive malignancy within the last 5 years, except for treated basal cell carcinoma of the skin, cervical intraepithelial neoplasia, or non-invasive dcis of the breast. * upper rectal cancer that is located above the peritoneal reflection. * primary tumour associated with any one of the following features: * frank intestinal obstruction, or * endoscope unable to pass through the tumour's lumen plus worsening local obstructive symptoms. note: patients with such features should be assessed by the surgical team regarding stomal bypass prior to study enrolment. such patients can still be considered for study enrolment after undergoing stomal bypass. * known hypersensitivity reaction to the study drugs (i.e. fluoropyrimidine, irinotecan, oxaliplatin) * known peripheral neuropathy of grade 2 or more in severity. * patients who have received an experimental anticancer therapy within the last 28 days. * previous pelvic radiotherapy. previous oxaliplatin or irinotecan for the treatment of colon or rectal cancer * patient with hip prosthesis * major surgery within the last 28 days. exception: any patient who underwent stomal bypass for obstructing primary tumour within the last 14 days are still eligible, as long as the patient has sufficiently recovered from the surgery at the investigator's discretion.
pupillometry and nociception level index for the evaluation of pain in intensive care unit.

Conditions: Critical Illness

Summary: pain is a frequent symptom in the intensive care unit (icu). critical ill patients are often intubated and sedated which makes self-evaluation of pain impossible. pupillary dilatation is a reflex directly related to stimuli such as pain, which can be measured by quantitative pupillometry. several studies in icu showed a significant relationship between pupillary diameter variation and pain. the nociception level index (nol-index) is a recent noninvasive and continuous monitoring of pain essentially used in operating room. the aim of this study is to evaluate the pupillometry and nol index in critical ill patients in sedated patients under mechanical ventilation during the mobilization plus toilet (described in literature as not painful procedure) and tracheal suctioning (described as a painful procedure)

pain will be evaluated via i) pupillometry with 3 successive measurements ii) behaviour pain scale (bps) and critical care pain observation tool (cpot) score evaluated by an investigator (physician) iii) evolution of physiological parameters (ie heart rate, blood pressure, respiratory rate) iv) nociception level index (nol-index). the evaluation times will be 5 minutes before care procedures (mobilization plus toilet and tracheal suctioning), during the procedures (with the worst value recorded) and 5 minutes after the procedures. the procedures are: * a mobilization and toilet of the patient: a priori, not a very painful procedure. the pain will be evaluated every 5 minutes during the toilet. * tracheal suctioning: a procedure known to be painful. the painful will be evaluated just at the end of tracheal suctioning (once the tracheal suctioning catheter is removed from the endotracheal intubation).

Eligibility criteria:
inclusion criteria: * older than18 years old * under invasive mechanical ventilation * sedated with i) a richmond agitation sedation scale (rass) : ≥ -4 and \<1, ii) being unable to evaluate their pain by a visual numeric scale exclusion criteria: * ophthalmological diseases which could modify the pupillometric parameters * neurological diseases (damage of nerve iii, intracranial hypertension, stroke) * admitted in icu after resuscitated cardiac arrest * drugs that inhibit the effect of the sympathetic system (clonidine, dexmedetomidine) * patient under veno-arterial extracorporeal membrane oxygenation (va-ecmo) * patient treated by a neuromuscular blockade * a do-not resuscitate order * major hemodynamic instability prohibiting planned care procedures

Keywords: pain intensive care sedated ventilated nol icu pupillometry
the pilot study of chikungunya virus infections in southern taiwan

Conditions: Chikungunya Fever

Summary: this test is to be collected during the dengue outbreak samples, including samples back in the past and forward to close the case, investigating the prevalence of serum chikungunya virus infection, and against those suspected dengue fever, chikungunya disease-related tests conducted to clarify dengue and chikungunya disease of clinical judgment, rapid method to detect chikungunya virus and then develop.

during the execution of this project was ended march 1, 2012 to december 31, 2015, is expected to gather 300 suspected dengue infection, of whom 150 dengue-negative test results, test results of 150 dengue positive. and closed the case into prospective and retrospective analysis of the last sample into two parts. case closed after part of a prospective analysis of the study, subjects were required to complete consent forms and collect 20 ml blood samples, blood samples will be checked to identify dengue and chikungunya disease associated serum antigen-antibody reaction , pcr (polymerase chain reaction) test and sequence analysis and pathogen identification and separation, in order to identify the source of infection difference. in addition, retrospective analysis of the last part of the specimen, sucked "after the health of the host track dengue infection, host immune regulation changes, and possible interactions with viral hepatitis" (kmuh-irb-960195) collected by the inspection plan body, the number of samples included in the plan to close the case, and contact with the subjects, changes to inform the content of the plan to re-sign the consent form.

Eligibility criteria:
inclusion criteria: * suspected of being infected with dengue fever exclusion criteria: * none

Keywords: chikungunya fever chikungunya virus
compassionate use of deferiprone in patients with pkan

Conditions: Pantothenate Kinase-Associated Neurodegeneration

Summary: patients with pantothenate kinase-associated neurodegeneration (pkan) who have completed the apopharma-sponsored study tircon2012v1-ext and who wish to continue to take deferiprone will be offered the opportunity to receive it on a compassionate basis. patients will be followed locally by their own neurologist or other appropriate specialist.

patients with pkan who have completed both the randomized, blinded, placebo-controlled trial tircon2012v1 and its follow-up, the single-arm open-label extension study tircon2012v1-ext, may enroll in this compassionate-use/expanded access program in order to continue receiving the iron chelator deferiprone. participants in this program will be followed locally by their own neurologist or other appropriate specialist. patients will take deferiprone oral solution 80 mg/ml at the same dose they were prescribed in the tircon2012v1-ext clinical trial. safety monitoring of the patients will be performed. at a minimum, the program will continue until the analysis of the currently blinded tircon2012v1 trial is completed (approximately q4 2016), at which time it will be re-evaluated.

Eligibility criteria:
inclusion criteria: 1. completed study tircon2012v1-ext 2. able to adhere to program appointments and evaluation schedules 3. females of childbearing potential must have a negative pregnancy test result at the start of the program, unless the treating physician determines there is no reasonable risk of pregnancy because of significant incapacity. if applicable, they must meet at least one of the following criteria: use an effective method of contraception during the program and for 30 days following the last dose of deferiprone, or participate in a non-heterosexual lifestyle, or have a male sexual partner who has been sterilized, or be abstinent during the program and for at least 30 days after its completion. 4. fertile sexually active heterosexual males must agree to use an effective method of contraception during the program and for at least 30 days after its completion 5. patients and/or their authorized legal representatives must provide signed and dated written informed consent, and minors must additionally sign an assent form as per local regulatory requirements. exclusion criteria: patients will be excluded from taking part in the compassionate use program if the treating physician determines the presence of any medical, psychological, or psychiatric condition which in his/her opinion would cause participation in the program to be unwise

Keywords: pantothenate kinase-associated neurodegeneration pkan neurodegeneration with brain iron accumulation nbia deferiprone ferriprox
wound interdisciplinary teams (wit): a community- based pragmatic randomized controlled trial

Conditions: Wound of Skin

Summary: wounds that are slow to heal (chronic) may be managed in different ways. in ontario, care in the community for most of these is coordinated by the local community care access centre (ccac). one or more health professionals might deliver treatment, individually or as part of a wound care team, with different members having different kinds of training (interdisciplinary team), which may or may not include wound care. community treatment by interdisciplinary teams has been shown to be more effective and cost-effective for some long-standing health problems, but further scientific evidence is needed to determine if this is also true for chronic wounds. this study compares the usual way chronic wounds are being managed in the community with a so-called "intermediate care" approach. in this study, intermediate care will involve health service providers following certain agreed-upon steps (evidence-based best practice) from first contact with the client through assessment, treatment, and on to referral to a hospital specialty wound care team, if needed.

for certain types of chronic illness, planning case management and providing care according to evidence-based guidelines (published methods that have been supported scientifically) results in better clinical outcomes and better cost-effectiveness. wound management by interdisciplinary teams may have these advantages in both the community primary care setting and the hospital specialized care setting. systematic review of the literature indicated that the evidence was incomplete to support implementation of an intermediate care model for community management of chronic wounds. therefore, the ontario health technology advisory committee recommended that a field evaluation be conducted to provide stronger evidence about the relative effectiveness, cost-effectiveness and feasibility of managing chronic wounds in the community using both standardized, comprehensive primary care and a systematic method of referral to a specialty, multidisciplinary team based in a hospital

Eligibility criteria:
inclusion criteria: * adult (\>18 years of age) client with eligible wound type (not surgical, malignant or burns) referred to the toronto central ccac for wound management. * client (or substitute decision maker) provides written, informed consent. * someone in client's home (or substitute decision maker) must be able to speak english. exclusion criteria: * surgical wounds * burns * malignant wounds * clients who are designated palliative on ccac referral form

Keywords: community wound care systematic wound team referral advanced in-home nurse wound training
clinical comparison of length of cataract procedures with zeiss lumera versus older zeiss microscope

Conditions: Cataract

Summary: study design will be a mix of retrospective (older zeiss microscope previously in use at our surgery center) and prospective data collection with the lumera and callisto software. the lumera and callisto software system will be used for all cataract surgeries including toric analyses and lens placement.

needs assessment research on this topic is needed as over 3 million cataract surgeries are performed in the united states each year. the number of surgeries performed is growing as baby boomers age. reimbursements continue to decline, necessitating ever improving operating and surgical efficiencies in the operating room setting for physicians and small business owners to remain financially viable. new governmental regulations dictate that physician payments will be related to patient satisfaction and outcomes which may be better provided by newer and better surgical technologies. the lumera operating microscope and callisto software system provide several features that may enhance operating room flow including hd video screen and co-observant microscopes that can be independently adjusted to help operating room staff anticipate the needs of the surgeon. enhanced retroillumination would be expected to translate into fewer complications and more confidence during surgery which could lead to less operating time, phaco energy used and improved visual outcomes. the toric alignment assistance device may lead to more accurate toric placement and improved visual outcomes after surgery. target audience would include all cataract surgeons both high and lower volume. there is currently a dearth of published literature on this technology and its benefits in routine cataract surgery. there are no registered similar trials on clinicaltrials.gov

Eligibility criteria:
inclusion criteria: * visually significant cataract exclusion criteria: * not visually significant cataract
estimation of the minimal important difference and validation of foot and ankle instruments

Conditions: Foot Diseases; Ankle Disease

Summary: the present study investigates the minimal important change and validity of foot and ankle measures.

patients who are waiting for foot and ankle surgery are recruited from four large referral centers (peijas hospital, seinäjoki central hospital, central finland central hospital, oulu university hospital). participants fill in foot and ankle-specific, generic and sosiodemographic questionnaires on the day of surgery, 6 months after surgery, and 6 months 2 weeks after surgery. both pen-and-paper and electronic options for completing the questionnaire set are provided. the data obtained from the foot and ankle outcome score (faos), european foot and ankle society (efas) score, modified lower extremity functional scale (lefs), visual analog scale foot and ankle (vas-fa), manchester oxford foot and ankle (moxfa) questionnaire, and the foot and ankle ability measure (faam) are analyzed using the rasch measurement theory and several other psychometric approaches to investigate minimal important change, reliability, responsiveness and validity of foot and ankle pro instruments.

Eligibility criteria:
inclusion criteria: * full understanding of finnish language * undergoing foot or ankle surgery * at least 18 years old exclusion criteria: * unbalanced mental disorder such as schizophrenia or depression * age under 18 * does not understand finnish * undergoing operation other than foot or ankle

Keywords: foot ankle finnish validation faos efas lefs faam vas-fa moxfa
multisensory body and space representations (bases-extinction)

Conditions: Healthy; Blindness

Summary: to accurately control body movements to interact with objects, our brain needs representations of the body and the nearby space. the broader aim of this research project is to study the behavioural and physiological mechanisms involved in the constitution of these representations, to identify their neural bases, in order to better understand the dysfunctions in the context of neurological or developmental disorders.


Eligibility criteria:
inclusion criteria: * male or female aged 5 to 71 * subject affiliated to the general social security scheme or a similar scheme * subject agreeing to participate in the study with informed consent -capable of understanding information and simple instructions related to the study exclusion criteria: * subject under tutelage or guardianship- subject under tutelage or guardianship * subject not able to give informed consent, unable to receive information about the study * subject not affiliated to a french or non-french social security system holder of a european health insurance card

Keywords: stroke multisensory plasticity body space mri